(61 days)
The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.
The Synthes 3.5mm Spring Plate is a variation of the Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the Synthes 3.5mm Spring Plate, outlining its device name, classification, predicate device, description, intended use, and a claim of substantial equivalence to the predicate device. It also includes the FDA's clearance letter.
Therefore, I cannot provide the requested information, as there is no mention of:
- Acceptance criteria table or reported device performance against such criteria.
- Details about a study, including sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.